NYT -- Smallpox Vaccine Stockpile Is Larger Than Was Thought
March 29, 2002
Smallpox Vaccine Stockpile Is Larger Than Was Thought
By GINA KOLATA and LAWRENCE K. ALTMAN
Federal officials said yesterday that they might
now have access to much more smallpox
vaccine than had been thought, a finding that
many said changed their options in responding to a
terrorist attack with smallpox.
The 15.4 million doses in a government stockpile can
be diluted with confidence fivefold without losing
potency. In addition, a drug company, Aventis
Pasteur, said it had more than 85 million doses of
vaccine, which has been stored, frozen, for decades.
An official of the company said in an interview that
tests showed that the vaccine was still effective.
Other tests are under way to see if it too can be
stretched to cover more people. [Page A19.]
The existence of the Aventis stockpile was reported yesterday in The Washington Post.
Most health officials are not advocating resumption of mass vaccination against smallpox, because the vaccine itself
can kill and cause injuries, including brain damage. But the disclosure that vaccine supplies are more abundant than
had been thought is likely to reignite the debate about how the government should prepare for what most consider
the remote possibility of a terrorist attack involving smallpox.
Richard J. Markham, chief executive for the American operations of Aventis Pharma, the parent company of
Aventis Pasteur, said in an interview yesterday that the company had told the Department of Health and Human
Services about its vaccine stockpile years ago but that the government had shown little interest until after the
terrorist attacks last fall. Federal officials, who spoke on condition of anonymity, said the government began
negotiations with the company about the stockpile in October but did not disclose its existence because of national
security concerns, legal issues and questions about whether the vaccine was effective.
In a news conference conducted by telephone yesterday, Tommy G. Thompson,
the secretary of the Department of Health and Human Services, deflected
questions about the Aventis vaccine and the negotiations with the company. Mr.
Thompson said he would provide more information today, but added, "We expect
this to turn out to be more good news."
Routine vaccination against smallpox, a highly infectious viral disease that killed
about a third of those who contracted it, was abandoned in the United States in
1972 and the disease was declared eradicated from the world in 1980. The only
two official stocks of the virus are held by Russia and the United States. But
many experts on terrorism say it is possible that stocks of the virus may exist in
other hands.
Because much of the world's population has not been vaccinated against the
disease and because the immunity from vaccination is believed to wane, the
release of the smallpox virus could be catastrophic.
The Centers for Disease Control and Prevention announced months ago that if an
outbreak occurred it would isolate infected people and vaccinate those who had
come in contact with them. This tactic, ring vaccination, was used by the centers
and the World Health Organization to eradicate the disease. The smallpox vaccine
is expected to protect people if it is given in the first four days after they are
exposed to the virus.
But some medical experts call for a national dialogue on the best way to prepare
for a possible smallpox outbreak that was spread by terrorists.
In an editorial in a forthcoming issue of The New England Journal of Medicine, made public yesterday, Dr. Anthony
Fauci, the director of the National Institute of Allergy and Infectious Diseases, said there was "considerable
skepticism" about the C.D.C.'s plan, despite what he called the soundness of its approach and its success in the
past.
"I would like to hear it debated," Dr. Fauci said in an interview, perhaps in Congressional hearings or even in
televised town meetings.
"A decision about what your approach is going to be should be done in a way that the American public can
understand why those decisions are going to be made," he said.
"You want to have that kind of discussion in the absence of the horror that accompanies an ongoing attack," Dr.
Fauci said.
In the same issue of the medical journal, which released the articles early citing the widespread interest in smallpox,
Dr. William J. Bicknell of Boston University School of Public Health, criticized the ring vaccination approach, saying
it is based on optimistic assumptions about how fast the virus would spread and how the public would respond.
"An epidemic is highly likely to outrun the vaccinators," Dr. Bicknell wrote. "Effective enforcement of quarantine is
also difficult. Official reassurances followed by further uncontrolled outbreaks could provoke panic, flouting of
authority and even the breakdown of medical and public health services."
But even critics of the disease control agency's plan are not necessarily advocating a return to mass vaccinations.
The chances of a smallpox attack are generally deemed to be low, and the vaccine can have severe, even lethal, side
effects.
While these reactions are rare — one to two out of every million people vaccinated die and a few hundred out of
every million have severe reactions, a number that is high enough to cause health experts to question the wisdom of
mass vaccinations.
"If there were absolutely no toxicity whatsoever to the smallpox vaccine, there would be very little debate," Dr.
Fauci said at a news conference on yesterday. "We could eliminate the threat of a smallpox bioterrorism attack."
Writing for the April 25 issue of The New England Journal of Medicine, Dr. Fauci, Dr. Jeffrey M. Drazen, the
journal's editor, and Dr. Bicknell urge the public to consider agonizing choices: Voluntarily immunize everyone with
a vaccine that could kill about 200 Americans, leave some alive but brain damaged, and disfigure others with deep
and permanent scars. Or save the vaccine for an attack and use ring vaccination and assume it would contain the
epidemic.
Some experts, like Dr. Jonathan B. Tucker, author of "Scourge: The Once and Future threat of Smallpox" (Atlantic
Monthly Press, 2001), said they would like to see more information on how real the bioterrorist threat was.
Dr. John Modlin, who heads a committee of experts that advises the disease control agency on immunization, said
the group was considering who should have access to the vaccine and expected to discuss the issue and possibly
make recommendations at a meeting in June.
Dr. Modlin said he expected that his group would not recommend vaccinating everyone because the vaccine was so
risky. The most difficult question, he said, was deciding if some people should be offered the vaccine because they
would help in an emergency.
"In some parts of the country state and local health officials feel strongly that their first responders should be
immunized," Dr. Modlin said. "At the federal level, officials want to keep those numbers small."
It would be difficult to identify those who should be vaccinated, he said, adding: "The more we immunize, the more
we increase the likelihood of adverse events. If we immunize tens or hundreds of thousands there will be serious
adverse events, possibly even deaths. The question is whether that is good public health policy." The C.D.C. usually
accepts the committee's recommendations but in this case, Dr. Modlin said, the final decision might be made by Mr.
Thompson or President Bush.
Dr. Jeffrey Hunker, a national security expert who is dean of the Heinz School of Public Policy and Management at
Carnegie Mellon University, said he did not envy the person who had to make the final decision about the smallpox
vaccine.
"It may in fact be our best choice to vaccinate everybody, but the fact is that you are literally going to have poster
children who are dying from the vaccination," Dr. Hunter said. "This presents one of the most difficult public policy
choices anyone is ever going to have to face."
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